MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problem Device Alarm System (1012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2024

Event Type  malfunction  

Event Description

The customer reported that the monitor did not alarm properly; the red alarm did not activate only yellow alarm although patient went into ventricular tachycardia (v-tach).The device was in use on patient at time of event, there was no adverse event reported.A philips remote service engineer (rse) spoke with the customer and the customer alleged that the monitor did not alarm properly; the red alarm did not activate only yellow alarm although patient went into v-tach¿.The rse informed that the customer needed configuration password for mx40.The rse gave the customer passwords for mx40's only to resolve the reported issue.A good faith effort (gfe) was made to obtain additional information and resolution for the case.In response, it was noted that the alarm issue did not cause any patient harm and configuration password resolved the reported issue.Based on the information available, the cause of the reported problem was due to the configuration issue of the device.The reported problem was confirmed.The engineer provided the configuration password to the customer to resolve the reported issue.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18845900
• MDR Text Key: 337695478
• Report Number: 1218950-2024-00163
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: 00884838082236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1